GTR Test Accession:
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GTR000611948.1
CAP
Last updated in GTR: 2023-08-25
View version history
GTR000611948.1, last updated: 2023-08-25
Last annual review date for the lab: 2023-09-01
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At a Glance
Test purpose:
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Predictive;
Prognostic;
Therapeutic management
Conditions (2):
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Solid tumor; Hematologic neoplasm
Analytes (3):
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EGFRvIII altered splicing; MET exon 14 altered splicing; fusion detection
Methods (1):
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Molecular Genetics - RNA analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Patients with advanced solid and hematologic malignancies, considered for targeted …
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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xR
Specimen Source:
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- Bone marrow
- Frozen tissue
- Paraffin block
- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Licensed Physician
Contact Policy:
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Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order:
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To order the Tempus xT, xR or xF test:
1. Retrieve a Tempus blood or saliva collection kit. All required forms are contained in the box.
2. Complete the Consent Form with the patient.
3. Complete the Requisition Form. Physician and Patient signatures are both required.
4. Complete the …
1. Retrieve a Tempus blood or saliva collection kit. All required forms are contained in the box.
2. Complete the Consent Form with the patient.
3. Complete the Requisition Form. Physician and Patient signatures are both required.
4. Complete the …
Order URL
Test service:
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Clinical Testing/Confirmation of Mutations Identified Previously
DNA sequencing
Comment: Tempus xT: DNA sequencing for 648 genes (Tumor and matched normal)
RNA sequencing
Comment: Tempus xR: RNA whole transcriptome sequencing
DNA sequencing
Comment: Tempus xF: ctDNA sequencing for 105 genes
DNA sequencing
Comment: Tempus nP: DNA sequencing for 13 genes with known roles in pharmacodynamics, pharmacokinetics, and immune responses to certain medications
DNA sequencing
Comment: Tempus xT: DNA sequencing for 648 genes (Tumor and matched normal)
RNA sequencing
Comment: Tempus xR: RNA whole transcriptome sequencing
DNA sequencing
Comment: Tempus xF: ctDNA sequencing for 105 genes
DNA sequencing
Comment: Tempus nP: DNA sequencing for 13 genes with known roles in pharmacodynamics, pharmacokinetics, and immune responses to certain medications
Test development:
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Test developed by laboratory (no manufacturer test name)
Informed consent required:
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Based on applicable state law
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Test Order Code,
Lab contact for this test,
Test strategy
Conditions
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Total conditions: 2
Condition/Phenotype | Identifier |
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Test Targets
Analytes
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Total analytes: 3
Analyte | Associated Condition |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument
RNA analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
Novaseq 6000
Clinical Information
Test purpose:
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Predictive;
Prognostic;
Therapeutic management
Target population:
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Patients with advanced solid and hematologic malignancies, considered for targeted therapies, unlikely to respond to conventional chemotherapies, or for whom no conventional therapies exist.
Variant Interpretation:
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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No.
No.
Will the lab re-contact the ordering physician if variant interpretation changes?
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No.
No.
Recommended fields not provided:
Clinical validity,
Clinical utility,
What is the protocol for interpreting a variation as a VUS?,
Is research allowed on the sample after clinical testing is complete?,
Sample negative report,
Sample positive report
Technical Information
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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In specimens with a tumor content of at least 20%, post macrodissection (if necessary), clinical sequencing is optimized to generate at least 50,000,000 unique reads. At 20% tumor content limit of detection (LOD), positive percentage agreement (PPA) and negative percentage agreement (NPA) for targeted rearrangements/fusions are 100.0% and 99.9%, respectively. …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
CAP Testing Information Help
Fusion RNA; RNA sequencing; RNA
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
CAP Testing Information Help
Fusion RNA; RNA sequencing; RNA
VUS:
Software used to interpret novel variations
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N/A
N/A
Recommended fields not provided:
Test Confirmation,
Assay limitations,
Description of internal test validation method,
Citations for Analytical validity,
Description of PT method
Regulatory Approval
FDA Review:
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Not provided
Additional Information
Reviews:
Clinical resources:
Consumer resources:
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Patients and consumers
with specific questions about a genetic test should contact a health care provider or a genetics professional.